Methods and Systems for Lingual Movement to Manipulate an Object

ABSTRACT

An intra-oral system is disclosed for assisting an individual in developing intra-oral muscle control and strength. The system may also be used to enable an individual having limited use of the upper extremities to control an electrical apparatus such as a wheelchair, a bed or a light fixture. The intra-oral system includes a mouthpiece having a plurality of air cells embedded therein. The air cells are configured to receive pressure applied by the tongue of an individual. Movement of the tongue over and against the air cells causes an object to be moved over a display. In one embodiment, the object is moved through an obstacle course or over a simulated track as part of a therapeutic regimen. In another embodiment, a character or icon on the display is selected and activated to manipulate an electrical apparatus. Methods for moving an electrical apparatus using a mouthpiece controlled through lingual movement are also provided.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of a provisional patent applicationbearing U.S. Ser. No. 61/096,408, filed Sep. 12, 2008. That applicationis entitled “Methods and Systems for Improving Mastication andDeglutition.” The provisional patent application is incorporated hereinby reference in its entirety.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not applicable.

THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT

Not applicable.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to therapeutic devices. More specifically,the present invention relates to methods and systems for helpingpatients improve mastication and deglutition. The present invention alsohas application to the movement of an object on a visual display inorder to activate an electrical apparatus.

2. Technology in the Field of the Invention

Mastication, or chewing, is the process by which food is mashed andcrushed by teeth. Mastication increases the surface area of food andallows it to more efficiently be broken down by enzymes. This is thefirst step of digestion.

During the mastication process, food is positioned between the teeth forgrinding by the cheek and tongue. As chewing continues, the food is madesofter and warmer. Enzymes in the saliva begin to break downcarbohydrates in the food. After chewing, the food (now called “bolus”)is swallowed. It enters the esophagus and continues on to the stomachwhere the next step of digestion occurs.

Many foods require at least some chewing for proper digestion. However,some individuals lack the muscular ability to grind food with theirtongue and teeth. Physical difficulty in chewing food may arise in youngpatients due to a neurological or muscular birth defect. Alternatively,such a difficulty may arise in older patients due to a partial stroke orinjury. Such individuals are thus limited in what they can eat.

There are also some individuals who have trouble swallowing food andsaliva. All food and saliva must be swallowed. Patients who lack themuscular ability to swallow food also cannot eat properly. Such acondition is referred to as dysphagia.

Deglutition, or swallowing, is the complex process by which food andsaliva are moved from the mouth, through the pharynx, and into thestomach. Both food and air pass through the pharynx, a part of the neckand throat positioned immediately posterior to the mouth and the nasalcavity, superior to the larynx, esophagus, and trachea. In other words,the pharynx (along with the esophagus and larynx), is part of both therespiratory system and digestive system in humans.

Deglutition is actually a two phase process involving both the somatic(voluntary) and autonomic (involuntary) nervous systems. For swallowing,the voluntary phase is referred to as the buccal phase, while theinvoluntary phase occurs as food is moved from the oral cavity into thepharynx.

Concerning the buccal phase, this phase occurs when a bolus, a soft massof sufficiently chewed food mixed with saliva, is transferred to theback of the tongue. The anterior portion of the tongue lifts toward thehard palate in the mouth and then descends backwards to force the bolusinto the pharynx. Next, the posterior portion of the tongue lifts towardthe soft palate, elevating the uvula to seal off the nasopharynx. Thisprevents the bolus from entering the nasal cavity. The buccal phaseinvolves cranial nerves V, VII, and XII, and is controlled by thesomatic nervous system.

Once the bolus has entered the pharynx, receptors trigger an involuntaryresponse by the deglutition center in the brain. Thispharyngeal-esophageal phase involves cranial nerves V, IX, X, XI, andXII. Pharyngeal folds on either side of the bolus are drawn together tocreate a narrow passageway. The bolus is forced through the pharynx byperistalsis, which is a series of involuntary muscle contractions. Atthe same time, the hyoid bone and larynx move upward and forward. Thiscauses the epiglottis to swing backwards, where it blocks the opening tothe larynx. The bolus can now pass only into the esophagus; all otheropenings have been blocked. The esophageal sphincter relaxes, allowingthe bolus to enter.

During the brief time that the larynx is sealed off, the swallowingcenter directly inhibits the respiratory center, halting respiration.Once the bolus enters the esophagus, peristalsis continues to force thefood onward toward the stomach while the pharynx returns to its restingstate. This is the involuntary process which occurs once food enters thepharynx.

During respiration, air travels from the oral or nasal cavity into thepharynx and then on through the larynx to the trachea and lungs. Whenfood is swallowed, it travels from the oral cavity into the pharynx, andthen into the esophagus. During swallowing, a flap of tissue called theepiglottis (part of the larynx) folds down to direct food away from thetrachea and into the esophagus, thus preventing aspiration of food intothe lungs. Faulty chewing or swallowing may lead to malnutrition,dehydration, airway obstruction (choking), aspiration pneumonia, andeven death.

Dysphagia may arise in young patients due to a neurological or muscularbirth defect. Alternatively, it may arise in older patients due to apartial stroke or loss of muscle strength. If the muscles of the tongueor cheek are weak or are not functioning properly, it may be difficultto move food around in the mouth for proper chewing. Food pieces thatare not chewed properly may be too large to swallow and can block thepassage of air when they enter the throat.

A need exists for a device that assists patients in strengthening theintra-oral musculature and in improving muscular control in connectionwith mastication and deglutition. A need further exists for a system bywhich a patient's ability to chew and swallow food may be improved bymeans of muscle therapy and visual feedback. A need further exists foran intra-oral system by which an individual may control an object on avisual display for activating an electrical apparatus.

BRIEF SUMMARY OF THE INVENTION

An intra-oral system is first provided. In one application, the systemis beneficial for assisting an individual in developing intra-oralmuscle control and strength. This, in turn, assists the patient indeglutition and mastication. The individual may be a patient undergoingtherapy.

In another application, the system may be used by an individual who issignificantly impaired in the use of his or her upper extremities. Thesystem enables this individual to move an object on a visual display.Using the visual display, this individual may actuate an electricalapparatus. Further, this individual may “type” a message on a digitalkeyboard.

In one embodiment, the intra-oral system includes a mouthpiece. Themouthpiece includes a bulb fabricated from an elastomeric material.Examples of elastomeric materials include polyisoprene rubber, silicon,chloroprene rubber, neoprene, styrene butadiene rubber, acrylonitrilebutadiene rubber, ethylene propylene diene methylene, polyvinylchloride,polyethylene, polyurethane, urethane-coated nylon, ethyl vinyl acetate,and combinations thereof.

The mouthpiece has a plurality of air cells embedded therein. The aircells are configured to receive pressure applied by the tongue of anindividual. In one embodiment, the mouthpiece comprises at least threeouter or radial air cells, with the air cells being disposed radiallyaround a centerpoint. The centerpoint may simply be a geographical pointof centricity, or it may define a separate air cell. The air cells areseparated by walls fabricated within the mouthpiece.

The intra-oral system also includes a plurality of air tubes. Each airtube has a proximal end and a distal end. The distal end of each of theair tubes is in substantially sealed fluid communication with acorresponding air cell. This may be by means of an integral connectionbetween the distal end of the air tubes and respective walls. Each ofthe plurality of air tubes may generally reside at ambient pressure.Alternatively, and by way of example, each of the plurality of air tubesmay be pre-loaded at a pressure of about 15 psi to 25 psi.

A plurality of transducers is also provided as part of the intra-oralsystem. Each transducer is in substantially sealed fluid communicationwith the proximal end of a corresponding air tube. The transducersconvert changes in air pressure within the respective air cells tocorresponding electrical signals. Such electrical signals may be, forexample, voltage signals, current signals, or resistive changes. Thetransducers are preferably in the nature of pressure sensors.

The intra-oral system also includes a processor. The processor serves toprocess the electrical signals. The electrical signals, such as voltagesignals, are modulated to generate a pressure profile from the aircells. The pressure profile represents a magnitude of pressure withinthe air cells, a direction of pressure, a duration of pressure, orcombinations thereof.

The processor is controlled by an algorithm, which in turn is written toperform a designated operation. In one aspect, the operation relates tothe movement of an object through an obstacle course. In this context,the intra-oral system may be used by a patient for therapy. In anotheraspect, the function relates to the movement of a cursor across akeyboard. The keyboard will have alphanumeric or other characters. Inthis context, the intra-oral system may be used by a patient or otherindividual to move the cursor to, for example, control the direction andmovement of a wheelchair or to activate or deactivate apparatus' orother electrical objects.

The intra-oral system also includes a display. The display is inelectrical communication with the processor. The display provides avisual output to move an object in accordance with the pressure profile.The object is manipulated by application of pressure on the air cells bylingual movement.

The pressure profile is based upon pressure readings from the variousair cells. In one aspect, air pressure signals are processed such that:

each electrical signal represents an air pressure reading from acorresponding air cell; and

electrical signals associated with one or more corresponding air cellsare averaged over a specified period of time to produce the pressureprofile, the pressure profile having a peak indicative of location atwhich air pressure is being generated within the one or more air cellsduring the specified period of time.

In one aspect, a magnitude of each electrical signal is recorded as partof the pressure profile over the specified period of time. The object isthen caused to be moved on the display in the direction indicated by thepressure profile at a velocity that generally corresponds to themagnitude of the electrical signals. In another aspect, an applicationof pressure by a patient on the centerpoint for a specified period oftime and at a specified magnitude causes a location of the object to bereset to a beginning point on the display. Alternatively, an applicationof pressure by a patient on a designated radial air cell for a specifiedperiod of time and at a specified magnitude causes a location of theobject to be moved to a corresponding location on the display.

In another aspect, an application of pressure by a patient on thecenterpoint for a specified period of time and at a specified magnitudecauses the object to jump over an obstacle on the display or to activateor deactivate an appliance or other electrical object. Alternatively, adouble-clicking of application of pressure by a patient on thecenterpoint for a specified period of time and at a specified magnitudecauses a location of the object to be reset to a beginning point on thedisplay, or causes the object to jump over an obstacle on the display.

A method for improving intra-oral motor skills of a patient is alsoprovided herein. In one embodiment, the method includes providing anintra-oral system. The intra-oral system is generally designed asdescribed above. In this respect, the system has a mouthpiece thatdefines an elastomeric bulb. The bulb has a plurality of air cellsembedded therein for receiving pressure applied by the tongue of apatient.

The intra-oral system also includes a plurality of air tubes. The distalend of each of the air tubes is in substantially sealed fluidcommunication with a corresponding air cell. The intra-oral systemfurther includes a plurality of transducers. The transducers convertchanges in air pressure within the air cells to electrical signals.

The intra-oral system also includes a processor for processing theelectrical signals. The electrical signals, such as voltage signals, aremodulated to generate a pressure profile from the air cells. Thepressure profile represents a magnitude of pressure within the air cellsat a particular time, a direction of pressure, a duration of pressure,or combinations thereof.

The pressure profile is based upon pressure readings from the variousair cells. In one aspect, air pressure signals are processed such thateach electrical signal represents an air pressure reading from acorresponding air cell. Electrical signals from one or morecorresponding air cells are averaged over a specified period of time toproduce the pressure profile. The pressure profile has a peak indicativeof location at which air pressure is being generated within the one ormore air cells during the specified period of time.

The intra-oral system also includes a display. The display is inelectrical communication with the processor. The display has a visualoutput to move an object in accordance with the pressure profile. Themethod then also includes the steps of placing the plurality of airtubes in fluid communication with the corresponding plurality oftransducers, and placing the processor in electrical communication withthe display.

The method next includes causing an object on the display to move inaccordance with the pressure profile. This is done by means of lingualmanipulation, meaning that the user applies pressure to the air cellsusing their tongue.

The user may be, for example, a patient who is in therapy. Here, theobject is moved by the patient as part of therapy. Movement of theobject helps the patient develop intra-oral muscle strength andcoordination for mastication and deglutition. Alternatively, a user maybe an individual who has limited mobility or dexterity in their upperextremities. The object is moved by the user to operate a wheelchair ora bed.

In one aspect, a magnitude of each electrical signal is recorded as partof the pressure profile over the specified period of time. The object isthen caused to be moved on a display in the direction indicated by thepressure profile at a velocity that corresponds to the magnitude of theelectrical signals. In another aspect, an application of pressure by apatient on the centerpoint for a specified period of time and at aspecified magnitude causes a location of the object to be reset to abeginning point on the display. Alternatively, an application ofpressure by a patient on a designated outer air cell for a specifiedperiod of time and at a specified magnitude causes a location of theobject to be moved to a corresponding location on the display.

Finally, a method for manipulating an electrical apparatus using lingualmusculature is also provided herein. In one embodiment, the methodincludes providing an intra-oral system. The intra-oral system isgenerally designed as described above. In this respect, the system has amouthpiece that defines an elastomeric bulb. The bulb has a plurality ofair cells embedded therein for receiving pressure applied by the tongueof a patient.

The intra-oral system also includes a plurality of air tubes. In oneembodiment, each of the plurality of air tubes resides substantially atambient pressure. Alternatively, the air tubes may be pre-loaded to apressure of about 15 psi to 25 psi. The air tubes preferably have aninner diameter of about 0.05 inches to 0.5 inches.

The distal end of each of the air tubes is in substantially sealed fluidcommunication with a corresponding air cell. The intra-oral systemfurther includes a plurality of transducers. The transducers convertchanges in air pressure within the air cells to electrical signals.Changes in air pressure are communicated to the transducers by means ofthe air tubes.

The intra-oral system will also include a processor for processing theelectrical signals. These may be, for example, analog signals. Theelectrical signals are modulated to generate a pressure profile from theair cells.

The pressure profile is based upon pressure readings from the variousair cells. In one aspect, air pressure signals are processed such thateach electrical signal represents an air pressure reading from acorresponding air cell. Electrical signals from one or morecorresponding air cells are averaged over a specified period of time toproduce the pressure profile. The pressure profile has a peak indicativeof location at which air pressure is being generated within the one ormore air cells during the specified period of time.

The intra-oral system also includes a display. The display is inelectrical communication with the processor. The display has a visualoutput to move an object in accordance with the pressure profile.

The method also includes the steps of placing the plurality of air tubesin fluid communication with the corresponding plurality of transducers,and placing the processor in electrical communication with the display.The display, again, has a visual output. The method then includescausing an object on the display to move in accordance with the pressureprofile.

In one aspect, a magnitude of each electrical signal is recorded as partof the pressure profile over the specified period of time. The object isthen caused to be moved on a display in the direction indicated by thepressure profile at a velocity that corresponds to the magnitude of theelectrical signals. In another aspect, an application of pressure by apatient on the centerpoint for a specified period of time and at aspecified magnitude causes a location of the object to be reset to abeginning point on the display. Alternatively, an application ofpressure by a patient on a designated outer air cell for a specifiedperiod of time and at a specified magnitude causes a location of theobject to be moved to a corresponding location on the display.

In accordance with this method of manipulating an electrical apparatususing lingual musculature, a symbol is clicked. The symbol on thedisplay may be of any type. For example, the symbol may be a picture.Alternatively, the symbol may be one or more alphanumeric characters, anarrow, a picture (or icon), or a geometric figure. Using their tongue,the user clicks on a symbol on the display to activate (or move) anelectrical apparatus. The electrical apparatus may be a wheelchair.Alternatively, the electrical apparatus may be, for example, atelevision, a light fixture or an electro-mechanically operated door.

In one aspect, the mouthpiece comprises at least three outer air cellsdisposed radially around a centerpoint. The centerpoint may define aseparate air cell in fluid communication with one of the plurality ofair tubes.

In one aspect, the signal processor receives voltage signals from eachof the plurality of transducers. The processor then processes thesignals such that:

each voltage signal represents an air pressure reading from acorresponding air cell; and

voltage signals from one or more corresponding air cells are averagedover a specified period of time to produce the pressure profile, thepressure profile having a peak indicative of location at which airpressure is being generated within the one or more air cells during thespecified period of time.

BRIEF DESCRIPTION OF THE DRAWINGS

So that the manner in which the present invention can be betterunderstood, certain illustrations, charts and/or flow charts areappended hereto. It is to be noted, however, that the drawingsillustrate only selected embodiments of the inventions and are thereforenot to be considered limiting of scope, for the inventions may admit toother equally effective embodiments and applications.

FIG. 1 is a perspective view of an intra-oral system according to thepresent invention, in one embodiment.

FIG. 2A is a cross-sectional view of the mouthpiece from the system ofFIG. 1, in one embodiment. The cross-section is taken across a majoraxis of the mouthpiece.

FIG. 2B is another cross-sectional view of the mouthpiece from thesystem of FIG. 1. Here, the cross-section is taken across a minor axisof the mouthpiece.

FIG. 2C is a top view of the mouthpiece from the system of FIG. 1.Individual air cells are shown along with corresponding air tubes.

FIG. 3 is a cross-sectional view of the air tube bundle from the systemof FIG. 1, in one embodiment.

FIGS. 4A-4C present various arrangements for displays from the system ofFIG. 1.

In FIG. 4A, the display shows an object that is being moved through anobstacle course. The object is moved through lingual manipulation.

In FIG. 4B, the display shows directional keys for moving a wheelchairor a bed. The keys are activated by using a cursor that is moved throughlingual manipulation.

In FIG. 4C, the display shows a keyboard and icons for variouselectrical apparatus' that may be operated using a cursor that is movedthrough lingual manipulation.

FIG. 5 provides a flowchart for a method for improving intra-oral motorskills of a patient, in one embodiment.

FIG. 6 provides a flowchart for a method for manipulating an objectusing lingual movement, in one embodiment

DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS

FIG. 1 is a perspective view of an intra-oral system 100 according tothe present invention, in one embodiment.

The intra-oral system 100 first includes a mouthpiece 110. Themouthpiece 110 is configured to be selectively inserted into anindividual's mouth (not shown). The individual may be a patient who isin need of therapy to develop the intra-oral musculature. Such a patientmay be, for example, a stroke victim or the victim of a head or neckinjury. Alternatively, such a patient may be a child who suffers fromcongenital limitations in chewing food and/or swallowing food.

The mouthpiece is preferably fabricated from an elastomeric material.Suitable materials may include polyisoprene rubber, chloroprene rubber,neoprene rubber, styrene butadiene rubber, and acrylonitrile butadienerubber. Additional suitable examples include silicon, ethylene propylenediene methylene, polyvinylchloride, polyethylene, polyurethane,urethane-coated nylon, and ethyl vinyl acetate. Combinations of thesematerials may also be employed.

Enlarged drawings of the mouthpiece 110 are provided in FIGS. 2A-2C.FIG. 2A is a cross-sectional view of the mouthpiece 110 from the systemof FIG. 1, in one embodiment. The cross-section is taken across a majoraxis. FIG. 2B is another cross-sectional view of the mouthpiece 110 fromthe system of FIG. 1. Here, the cross-section is taken across a minoraxis. FIG. 2C is a top view of the mouthpiece 110 from the system ofFIG. 1. Features of the mouthpiece 110 will be discussed with referenceto these three figures together.

The mouthpiece 110 is designed to be substantially hollow. To this end,the mouthpiece 110 defines a bottom surface 112 and a top surface 114.The bottom surface 112 is preferably substantially flat while the topsurface 114 is preferably curved to create an arcuate profile. Thus, themouthpiece 110 is in the nature of a bulb.

The mouthpiece 110 also includes a plurality of air cells 115, 118. Inthe arrangement of FIGS. 2A-2C, six air cells 115, 118 are provided.These represent a central air cell 115 and then separate air cells 118spaced radially around the central air cell 115. Preferably, at leastthree radial air cells 118 are provided. In the illustrative arrangementof FIGS. 2A-2C, the mouthpiece 110 has five radial air cells 118. Theradial air cells 118 preferably are equi-radial in dimension, meaningthat each air cell 118 forms a substantially equal angle extending froma center point of the mouthpiece 110.

Each air cell 115, 118 holds a volume of air. Preferably, the air isheld at ambient pressure. Alternatively, the air in the air cells 115,118 is pre-loaded at a higher pressure such as between about 15 psi and25 psi. In this way, the mouthpiece 110 is resistive to pressure placedby the patient using his or her tongue.

To define the air cells 115, 118, the mouthpiece 110 includes a seriesof walls 119. The walls 119 are sealed between the bottom surface 112and the top surface 114. Sealing may be through heat sealing, RFsealing, or other mechanisms known in the art of plastic injectionmolding or other molding techniques.

The mouthpiece 110 may be configured in different sizes. The size willprimarily be dictated by the size of the individual user's mouth. It isnoted that for smaller patients, fewer air cells may be required due tosize limitations.

The intra-oral system 100 also includes a plurality of air tubes 125. Anair tube 125 is provided to correspond to each radial air cell 118.Optionally, an air tube 125 is also provided for the central air cell115. The air tubes 125 are sealingly disposed within the walls 119 ofthe mouthpiece 110. The air tubes 125 are preferably manufactured to beintegral to respective walls 119.

It is noted that in the mouthpiece 110 of FIG. 2C, the central air cell115 receives an air tube 125. However, in some embodiments the centralair cell may be dead, meaning that it does not receive its own air tube125. Indeed, in another arrangement, the central air cell 115 holds noair, but just defines a center point in the mouthpiece 110.

The air tubes 125 exit the mouthpiece 110 through an end opening 116.The end opening 116 defines a circular orifice that frictionallyreceives a bundle of air tubes 125. The air tubes 125 extend fromrespective walls 119, travel through an end area 128 of the mouthpiece110 (which is not an air cell), travel through the end opening 116, andthen exit the mouthpiece 110.

In the mouthpiece 110 of FIG. 2C, the air tubes 125 connect to the walls119 internal to the mouthpiece 110, that is, through the end area 128and through the central air cell 115. However, some or all of the airtubes 125 may alternatively enter the air cells 115, 118 from a top, abottom or an outer edge of the bulb defining the mouthpiece 110. Thepresent inventions are not limited by the method of providing fluidcommunication between the air tubes 125 and the air cells 115, 118unless so provided in the claims.

In the arrangement of FIG. 1, the air tubes 125 are bundled as they exitthe mouthpiece 110. That means that the air tubes 125 are held togetherexternally by a tubular sheath 120.

FIG. 3 is a cross-sectional view of an air tube bundle 300 from thesystem of FIG. 1, in one embodiment. In the arrangement of FIG. 3, theair tube bundle 300 includes a tubular sheath 120. The tubular sheath120 helps to protect the air tubes 125 and keeps them from gettingpunctured or tangled. Six illustrative air tubes 125 are seen within thetubular sheath 120. Each air tube 125 defines an air channel 124 throughwhich air passes. It is understood that any number of air tubes 125 andcorresponding air cells 115, 118 may be used in the system 100.

Referring again to FIG. 1, the system 100 also includes a plurality oftransducers 140. The transducers 140 are in the nature of pressuresensors. The transducers 140 may be, for example, ASDX pressure sensorsmade by the Sensing and Control Division of Honeywell in Golden Valley,Minn. The ASDX series of pressure sensors utilize a small internaldiaphragm for sensing fine variations in pressure. Different sensors areoffered in the series for sensing within different pressure ranges. Suchranges include 0 to 1 psi, 0 to 5 psi, 0 to 15 psi, and 0 to 30 psi. TheASDX sensors offer a high level output (4.0 Vdc span) that is fullycalibrated and temperature compensated with on-board ApplicationSpecific Integrated Circuitry (ASIC).

The transducers 140 are preferably housed within an operational box 142.The box 142 has walls 148 and a top (not shown). The operational box 142will include an electrical circuit board 144 that places the transducers140 in electrical communication with one another as well as with a powersupply. A power switch for the operational box 142 is seen at 145.

The transducers 140 are in fluid communication with respective air cells115, 118. This is done by means of the air tubes 125. A proximal end ofeach air tube 125 is connected to a transducer 140 at a connection point155, while a distal end of each air tube 125 is connected to arespective air cell 115, 118, preferably at or through a respective wall119 in the mouthpiece 110.

Each of the air tubes 125 may extend unbroken from a transducer 140 toan air cell 115 or 118. However, it is preferred that a manifold 130 beprovided to enable connections of air tubes 125 inside and outside ofthe operational box 142. The manifold 130 includes a plurality of prongs132. Each of the prongs 132 defines a channel that extends from eachside of the manifold 130. This means that each prong 132 is actually apair of prongs, with one prong of a pair of prongs extending inside ofthe operational box 142, and another prong of the pair of prongsextending outside of the operational box 142. In this way, each pair ofprongs 132 enables fluid communication through the air tubes 125 withoutnecessity of the operator opening the box and exposing the delicatetransducers 140. Further, the therapist or other operator is notrequired to manipulate the fragile connection 155 between the air tubes125 and the respective transducers 140. Preferably, the air tubes 125are color-coded with the prongs 132 so that the air tubes 125 properlycorrespond to the correct transducers 140. Alternatively, other codingsystems may be used such as alphabetical or numeric associations, or theuse of symbols. Alternatively still, custom connectors which connect theair tubes 125 to the prongs 132 in only one orientation may be utilized.

It is noted again that the air tubes 125 are preferably bundled by atubular sheath 120. The tubular sheath 120 extends generally from themanifold 130 to the end opening 116 of the mouthpiece 110. A proximalend 122 of the tubular sheath 120 begins near the manifold 130, while adistal end 126 of the tubular sheath 120 covers the end opening 116 ofthe mouthpiece 110. In this way, the mouthpiece 110, the air tubes 125outside of the operational box 142, and the tubular sheath 120 areessentially one integral unit. Each patient is supplied with his or herown mouthpiece 110 having integrated air tubes 125 and the tubularsheath 120. The only “assembly” required by the therapist is to connectthe air tubes 125 with the external prongs 132 on the manifold 130.

The transducers 140 are designed to convert changes in air pressurewithin the air cells 115, 118 to electrical signals. The electricalsignals may be analog voltage signals. Other examples of electricalsignals that may be used include current signals or resistive changes.The changes in air pressure within the air cells 115, 118 are deliveredpneumatically to the transducers 140 through the respective air tubes125. As the transducers 140 sense an increase in air pressure, acorresponding voltage or other electrical signal is delivered throughthe electrical circuit board 144.

The intra-oral system 100 also includes a processor 150. The processor150 uses operational software for processing the electrical signals. Asshown in the arrangement for the system 100 of FIG. 1, the electricalsignals are delivered to the processor 150 by means of the electricalcircuit board 144. This means that the processor 150 also resides withinthe operational box 142. However, in another embodiment the processor150 resides outside of the operational box 142. In yet anotherarrangement, electrical signals may be sent through a wirelessconnection such as through use of Bluetooth technology.

In any instance, the electrical signals, such as voltage signals, aremodulated to generate a pressure profile from the air cells 115 and/or118. The pressure profile represents magnitude of pressure within theair cells 115 and/or 118. Alternatively or in addition, the pressureprofile represents a location or direction of pressure within the aircells 115 and/or 118. Alternatively or in addition, the pressure profilerepresents a duration of pressure applied to the air cells 115 and/or118.

The pressure profile is based upon pressure readings from the variousair cells, either individually or through some combination. In oneaspect, air pressure signals are processed such that each electricalsignal represents an air pressure reading from a corresponding air cell.Electrical signals from one or more corresponding air cells may beaveraged over a specified period of time to produce the pressureprofile. The pressure profile has a peak indicative of location at whichair pressure is being generated within the one or more air cells duringthe specified period of time.

The pressure profile can be used to determine direction. A curve-fittingtechnique may be used with the pressure readings of the outside ring ofair cells as data points. In one instance, a Gaussian curve-fittingtechnique is used to determine the peak pressure, yielding arepresentation of the radial direction from 0 to 360 degrees.

The pressure profile can be used to determine the magnitude of pressureapplied by the patient. The preferred method is to use the average valueof the pressure profile across all air cells 115, 118 to represent thismagnitude. In certain scenarios, the associated pressure value from thecentral air cell 115 can be solely used to determine the magnitude. Abaseline or steady-state value representing no pressure being applied tothe mouthpiece 110 may be subtracted from the pressure profile to moreaccurately determine the actual pressure applied by the patient.

When a pressure profile is generated, a normalization procedure may beused to remove differences in pressure-to-voltage characteristicsbetween air cells. These differences can arise due to manufacturingimperfections in the air cells 115, 118 and/or the electronics. Thenormalization values can be stored on the processor 150 and/or acomputer, seen at 160.

An electrical cord 146 extends from the operational box 142. Morespecifically, the cord 146 extends from an opening 147 in theoperational box 142. The cord 146 preferably has a USB connector 148 forplacing the processor 150 in electrical communication with a computer160. More specifically, the USB connector 148 places the processor 150in electrical communication with a processing unit 162 for a computer160.

The computer 160 is preferably a general purpose computer 160. Such acomputer may be a laptop computer or a desk top computer as may bepurchased at a local retail store. In this instance, communicationssoftware may be loaded onto the processing unit 162 by the therapist orIT representative. However, the processing unit 162 may be a speciallydesigned or dedicated unit that comes with the operational box 142.Alternatively, the processing unit 162 may be a central processing unitthat is part of a network.

In operation, the system 100 allows a patient to manipulate an object ona screen. This is done by the patient moving his or her tongue acrossand against the bottom surface 112 of the mouthpiece 110. Such movementcauses an increase in air pressure within selected air cells 115, 118.The increase in air pressure causes a corresponding increase in airpressure within the air tubes 125. This, in turn, is transmitted to therespective transducers 140 within the operational box 142.

Electrical signals are generated by the transducers 140 in response tothe changes in air pressure within the air tubes 125. These signals aresent to the processor 150. The processor 150, in turn, modulates thesignals and sends them to display software residing on the processingunit 162. Using the display or “game” software, an object (not shown inFIG. 1) is caused to be moved across a display 166. Manipulation of theobject allows the patient to increase strength within the oralmusculature, and to improve lingual dexterity.

To implement this function, the system 100 also includes the visualdisplay 166. The display 166 represents a screen for visualizing theobject as it is moved by the patient. The display 166 may include astand 168 for supporting the display 166. Preferably, the display 166 isadjustable to accommodate the height or position of the patient. A cord165 is offered to provide the needed electrical communication betweenthe processing unit 162 and the display 166 when the two are not part ofan integral device such as a laptop computer.

It is understood that the display 166 arrangement of FIG. 1 is merelyillustrative. The display 166 may be part of a laptop computer.Alternatively, the display 166 may be part of a headset, or may comprisea large, wall-mounted screen. Alternatively still, the display 166 maybe a screen that receives an image from a projector.

As part of therapy, the patient may be asked to move an object over atrack or through an obstacle course. FIG. 4A presents a display 400A ina first embodiment. An object 410 is shown ready to be moved over atrack 420. The object is moved through lingual manipulation.

The object 410 and the track 420 are indicated as mere geometric shapes.This is certainly an acceptable option. However, it is much preferredthat the object 410 and the track 420 present a more interestingsubject. For example, the object 410 may be a rabbit or other smallanimal, and the track 420 may be a garden or area of nature.Alternatively, the object 410 may be a motorcycle or other motorizedvehicle, and the track 420 may be a race track, a stunt track or an openroad. Alternatively still, the object 410 may be a horse or other racinganimal, and the track 420 may be a race track. Other examples includemaking the object 410 a skateboard, a snowboard, a cartoon characterthat talks, and so forth. In any instance, the display 400A may includeobstacles 425. The obstacles 425 may represent, for example, a fence ora water puddle that is to be jumped.

The display 400A is arranged for the purpose of providing therapy to apatient. However, the system 100 has application to other individualsbesides patients undergoing therapy. For example, the system 100 may beused by an individual who is a quadriplegic and must use theirintra-oral musculature to move objects. Such an individual may use awheelchair for mobilization. In that instance, the individual may usethe system 100 to operate the wheelchair. Alternatively, such anindividual may be bed-ridden and/or unable to fully use their arms. Inthat instance, the individual may use the system 100 to manipulate theposition of the bed.

FIG. 4B presents a display 400B for the system 100, in an alternateembodiment. In this system, an object is shown at 430. The object 430 isthe object to be moved by the individual through lingual manipulation.In this instance, the object 430 is a cursor or arrow that is movedacross the display 400B in accordance with the pressure profile. Morespecifically, a patient applies pressure to the various air cells in thebulb defining the mouthpiece 110 to ultimately cause translation of thecursor 430 on the display 400B.

The display 400B also includes directional keys. In this arrangement,the directional keys are for moving a wheelchair (not shown). However,the keys may be adapted to move the mattress on a bed frame. Thedirectional keys represent forward 432F and reverse 432R arrows.Actuation of these arrows 432F, 432R causes the wheelchair to moveforward or backward. The directional keys also represent clockwise 434Fand counter-clockwise 434R arrows. Actuation of these arrows 434F, 434Rcauses the wheelchair to rotate clockwise or counter-clockwise.

The keys 432F, 432R, 434F, 434R are activated by using the cursor 430.In one aspect, a key 432F, 432R, 434F, or 434R is activated by the userpositioning the cursor 430 over the selected key, and thendouble-clicking on the center air cell 115. In another aspect, a key432F, 432R, 434F, or 434R is activated by the user positioning thecursor 430 over the selected key, and then pressing against the centerair cell 115 for a designated period of time at a certain level ofpressure. In the instance where the center air cell 115 is “dead,” a key432F, 432R, 434F, or 434R may be activated by the user positioning thecursor 430 over the selected key, and then pressing against a designatedradial air cell 118 or in the center of the mouthpiece 110 for adesignated period of time at a certain level of pressure.

The display 400B of FIG. 4B is ideally supported on the individual'swheelchair or bed, as the case may be. For example, the mouthpiece 110will be mounted on an arm (not shown) that places the mouthpiece 110 inproximity to the user's mouth. In this way, the individual mayselectively insert the mouthpiece 110 into their mouth for movement ofthe wheelchair or bed. In addition, the operational box 142 for thetransducers 140 and the processor 150, along with the screen 166, arepositioned together on the wheelchair or on the bed. In this instance,the operational box 142 and the processor 150 are an integrated unit.

It is understood in this application that the display 166 will be inelectrical communication with a motor or servo-system on the wheelchairor the bed, as the case may be. In this way, the user's instructionsdelivered by moving the object 430 on the screen 400B cause thewheelchair or bed to respond.

The system 100 may be used by a physically-limited individual to operateother electrical apparatus' besides a wheelchair or a bed. Suchapparatus' include, for example, a television, a light fixture, athermostat or an electro-mechanically operated door. Further, the system100 may be used to allow the individual to type text messages using justtheir mouth.

FIG. 4C presents a display 400C for the intra-oral system 100, in analternate embodiment. In this display 400C, an object is again shown at430. The object 430 is the object to be moved by the individual throughlingual manipulation. The object 430 is again a cursor or arrow that ismoved across the display 400C in accordance with the pressure profile.

The display 400C includes icons 442. The icons 442 are pictures thatrepresent various apparatus' as listed above. The individual may selectan apparatus to be manipulated by moving the cursor 430 over thecorresponding icon 442. The user may then double-click on the center aircell 115 of the mouthpiece 110 to turn the apparatus on or off.

Arrow keys 444, 446 are also provided on the display 400C. The user mayfurther manipulate a selected electrical apparatus by double-clicking onan arrow key 444, 446. For example, a light fixture may be brightened ordimmed by double-clicking on the arrow keys 444, 446. Alternatively, thechannel of a television or radio may be changed by double-clicking onthe arrow keys 444, 446. Separate arrow keys (not shown) may be used tothen adjust the volume.

In lieu of double-clicking, an icon 442 or an arrow key 444, 446 may beselected or activated by the user positioning the cursor 430 over theselected icon 442 or key 444, 446, and then pressing against the centerair cell 115 for a designated period of time at a certain level ofpressure. In the instance where the center air cell 115 is “dead,” aselected icon 442 or key 444, 446 may be activated by the userpositioning the cursor 430 over the selected icon 442 key 444, 446, andthen pressing against a designated radial air cell 118 or in thecenterpoint of the mouthpiece 110 for a designated period of time at acertain level of pressure.

A signal is sent from the system 100 to the electrical apparatus. Thissignal is preferably a wireless signal such as through infraredtechnology, Bluetooth technology or other wireless technology that maybe known to those of ordinary skill in the art.

The display 400C also includes an optional keyboard 440. The keyboard440 allows the physically-limited individual to type in a textualmessage such as an e-mail message to another individual. The individualagain uses the cursor 430 to select alpha-numeric keys to be “pressed.”Pressing again means double-clicking or otherwise applying pressure to aselected air cell in the mouthpiece 110. By selecting and “pressing” aseries of digital keys on the keyboard 440, a message may be composed.The message may be seen on a visualization screen 448 on the display400C. The message may then be “sent” by pressing a return arrow 442. Inthis arrangement, the processor has a wired or wireless internetconnection for delivering the message through a communications network.

A method for improving intra-oral motor skills of a patient is alsoprovided herein. Improving motor skills will assist the patient inmastication and deglutition. FIG. 5 presents a flow chart, showing stepsfor generally performing the method 500, in one embodiment.

In accordance with FIG. 5, the method 500 first includes providing anintra-oral device. This is shown in Box 510. The intra-oral device isgenerally designed as described above in connection with FIGS. 1, 2A-2C,3, and 4A. In this respect, the device has an elastomeric mouthpiecethat defines a bulb. The bulb has a plurality of air cells embeddedtherein for receiving pressure applied by the tongue of a patient. Inone aspect, the mouthpiece comprises at least three outer air cellsdisposed radially around a centerpoint. The centerpoint may define aseparate air cell, or it may be a “dead” area. The cells are divided andsealed by walls.

The intra-oral device also includes a plurality of air tubes.Preferably, each of the plurality of air tubes resides substantially atambient pressure. Alternatively, each of the plurality of air tubes maybe preloaded at a pressure of about 15 psi to 25 psi. This createsdesirable additional resistance for more advanced patients. The airtubes preferably have an inner diameter of about 0.05 inches to 0.5inches. However, other dimensions may be employed.

The distal end of each of the air tubes is in substantially sealed fluidcommunication with a corresponding air cell. In one aspect, each of theair tubes comprises more than one tubular body operatively connected toform a single, pneumatically sealed channel. In this instance, amanifold may be used to provide a “quick-connect” between sets of airtubes.

The method 500 also includes the step of placing the plurality of airtubes in fluid communication with a corresponding plurality oftransducers. To this end, the intra-oral system includes a plurality oftransducers. This step is presented in Box 520. The transducersrepresent pressure sensors that are part of an electrical circuit. Thetransducers convert changes in air pressure within the air cells tovoltage or other electrical signals. The changes in air pressure withinthe air cells are delivered pneumatically to the transducers through therespective air tubes.

The method 500 also includes the step of providing a processor. Theprocessor receives the voltage signals from the transducers andprocesses them. This is shown in Box 530.

The method 500 further includes the step of placing each of theplurality of transducers in electrical communication with the processor.This is shown in Box 540. The processor may be placed within the samehardware packaging or box as the transducers. Alternatively, theprocessor may be a part of a laptop computer or a desktop computer.

The method 500 also includes the step of placing the processor inoperative electrical communication with a display. This step ispresented in Box 550. To effectuate this step, the intra-oral devicealso includes a display. The display has a visual output that presentsan object.

The method 500 also includes the step of generating a pressure profilefrom the air cells. This step is provided in Box 560. The pressureprofile is generated by the processor in response to the voltage orother electrical signals received from the transducers. The signals aremodulated to generate a pressure profile from the air cells. Preferably,the pressure profile represents a magnitude of pressure within the aircells, a direction of pressure, a duration of pressure, or combinationsthereof.

The pressure profile is based upon pressure readings from the variousair cells. In one aspect, air pressure signals are processed such thateach voltage signal represents an air pressure reading from acorresponding air cell. Voltage signals from one or more correspondingair cells are averaged over a specified period of time to produce thepressure profile. The pressure profile has a peak indicative of locationat which air pressure is being generated within the one or more aircells during the specified period of time.

The processor sends signals based on pressure profiles to a processingunit. The processing unit is part of a computer system. Signals are sentto the processing unit by means of a USB port or other electroniccommunications connection. Visualization software is downloaded onto theprocessing unit to enable the user to see an object being moved on adisplay.

The method further includes the step of causing an object on the displayto move. This is provided at Box 570. The object is moved by means oflingual manipulation of the mouthpiece. More specifically, a patientapplies pressure to the various air cells in the mouthpiece toultimately cause translation of the object on the display.

As part of therapy, the object may be moved through an obstacle course.For example, the object may be a rabbit or other animal, and the courseis a race track, a garden or an area of nature. As another example, theobject may be a motorized vehicle such as a car or a motorcycle. Themotorized vehicle is moved over a track, through simulated city streets,through simulated open roads, or even off road. Other visualizationschemes or “games” as described above may be implemented in accordancewith graphics software.

In one aspect, a magnitude of each voltage signal is recorded as part ofthe pressure profile over the specified period of time. The object isthen caused to be moved on the display in the direction indicated by thepressure profile at a velocity that corresponds to the magnitude of thevoltage signals. In another aspect, an application of pressure by apatient on the centerpoint for a specified period of time and at aspecified magnitude causes a location of the object to be reset to abeginning point on the display. Alternatively, an application ofpressure by a patient on a designated outer air cell for a specifiedperiod of time and at a specified magnitude causes a location of theobject to be moved to a corresponding location on the display.

In one aspect, the signal processor receives voltage signals from eachof the plurality of transducers. The processor processes the signalssuch that:

each voltage signal represents an air pressure reading from acorresponding air cell; and

voltage signals from one or more corresponding air cells are averagedover a specified period of time to produce the pressure profile, thepressure profile having a peak indicative of location at which airpressure is being generated within the one or more air cells during thespecified period of time.

In yet another aspect, an application of pressure by a patient on thecenterpoint for a specified period of time and at a specified magnitudecauses the object to jump over an obstacle on the display.

The air cells within the mouthpiece may also be configured to respond todouble-clicking by the patient. This means that the patient moves his orher tongue against a particular air cell or area of the mouthpiece twicewithin a designated period of time recognized by the processor. Forexample, double-clicking of application of pressure by a patient on acenterpoint for a specified period of time and at a specified magnitudemay cause a location of the object to be reset to a beginning point onthe display, or cause the object to jump over an obstacle on thedisplay.

A method for manipulating an electrical apparatus using lingualmusculature is also provided herein. FIG. 6 presents a flow chartshowing steps for generally performing the method 600, in oneembodiment.

In accordance with FIG. 6, the method 600 first includes providing anintra-oral device. This is shown in Box 610. The intra-oral device isgenerally designed as described above in connection with FIGS. 1, 2A,2B, 2C, 3, 4B and 4C. In this respect, the device has a mouthpiece thatdefines an elastomeric bulb. The bulb has a plurality of air cellsembedded therein for receiving pressure applied by the tongue of apatient. In one aspect, the mouthpiece comprises at least three outerair cells disposed radially around a centerpoint. The centerpoint maydefine a separate air cell, or it may be a “dead” area.

The intra-oral system also includes a plurality of air tubes.Preferably, each of the plurality of air tubes resides substantially atambient pressure. The air tubes preferably have an inner diameter ofabout 0.05 inches to 0.5 inches. However, other dimensions may beemployed.

The distal end of each of the air tubes is in substantially sealed fluidcommunication with a corresponding air cell. In one aspect, each of theair tubes comprises more than one tubular body operatively connected toform a single, pneumatically sealed channel. In this instance, amanifold may be used to provide a “quick-connect” between sets of airtubes.

The method 600 also includes the step of placing the plurality of airtubes in fluid communication with a corresponding plurality oftransducers. To this end, the intra-oral system includes a plurality oftransducers. This step is presented in Box 620. The transducersrepresent pressure sensors that are part of an electrical circuit. Thetransducers convert changes in air pressure within the air cells toelectrical signals. The changes in air pressure within the air cells aredelivered pneumatically to the transducers through the respective airtubes.

The method 600 also includes the step of providing a processor. Theprocessor receives the electrical signals from the transducers andprocesses them. This is shown in box 630.

The method 600 further includes the step of placing each of theplurality of transducers in electrical communication with the processor.This is shown in Box 640. Preferably, the processor is placed within thesame hardware packaging or box as the transducers. Alternatively, theprocessor may be a part of a laptop computer or a desktop computer.

The method 600 also includes the step of placing the processor inoperative electrical communication with a display. This step ispresented in Box 650. To effectuate this step, the intra-oral systemalso includes a display. The display has a visual output that presentsan object.

The method 600 also includes the step of generating a pressure profilefrom the air cells. This step is provided in Box 660. The pressureprofile is generated by the processor in response to the electricalsignals received from the transducers. The electrical signals aremodulated to generate a pressure profile from the air cells. Preferably,the pressure profile represents a magnitude of pressure within the aircells, a direction of pressure, a duration of pressure, or combinationsthereof.

The pressure profile is based upon pressure readings from the variousair cells. In one aspect, air pressure signals are processed such thateach electrical signal represents an air pressure reading from acorresponding air cell. Electrical signals from one or morecorresponding air cells are averaged over a specified period of time toproduce the pressure profile. The pressure profile has a peak indicativeof location at which air pressure is being generated within the one ormore air cells during the specified period of time.

The processor sends signals based on pressure profiles to a processingunit. The processing unit is part of a computer system. Signals are sentto the processing unit by means of a USB port or other electroniccommunications connection. Visualization software is downloaded onto theprocessing unit to enable the user to see an object being moved on adisplay.

The method further includes the step of causing an object on the displayto move. This is provided at Box 670. The object is preferably a cursoror arrow that is moved across the display in accordance with thepressure profile. The object is moved over a symbol that represents anelectrical apparatus to be activated or a change in the status of anelectrical apparatus. The symbol on the display may be of any type. Forexample, the symbol may be a picture of an electrical apparatus.Alternatively, the symbol may be one or more alphanumeric characters, anarrow indicating direction, or a geometric figure.

In one aspect, a magnitude of each electrical signal is recorded as partof the pressure profile over the specified period of time. The object isthen caused to be moved on a display in the direction indicated by thepressure profile at a velocity that corresponds to the magnitude of theelectrical signals. In another aspect, an application of pressure by apatient on the centerpoint for a specified period of time and at aspecified magnitude causes a location of the object to be reset to abeginning point on the display. Alternatively, an application ofpressure by a patient on a designated outer air cell for a specifiedperiod of time and at a specified magnitude causes a location of theobject to be moved to a corresponding location on the display.

In one aspect, the signal processor receives electrical signals fromeach of the plurality of transducers. The processor processes thesignals such that:

each electrical signal represents an air pressure reading from acorresponding air cell; and

electrical signals from one or more corresponding air cells are averagedover a specified period of time to produce the pressure profile, thepressure profile having a peak indicative of location at which airpressure is being generated within the one or more air cells during thespecified period of time.

The method 600 further includes the step of clicking on the symbol onthe display. Clicking is done through lingual manipulation. This step isshown at Box 680. Using their tongue, a user clicks on a symbol on thedisplay to activate or move an electrical apparatus. The electricalapparatus may be a wheelchair. Alternatively, the electrical apparatusmay be, for example, a television, a light fixture or anelectro-mechanically operated door.

The above descriptions are not intended to be limiting of scope of theinventions. For example, the present disclosure is not limited to amouthpiece 110 having the configuration shown in FIGS. 2A-C; otherconfigurations may be employed. The mouthpiece may only have, forinstance, two air cells placed in side-by-side relation. The mouthpiece110 preferably has a handle (not shown).

In another arrangement, the mouthpiece does not use air cells, air tubesand pressure sensors, but instead operates on a system where electricalsignals are sent directly from the mouthpiece. The mouthpiece may bearranged in a matrix, with pressure sensors being embedded directly intothe mouthpiece within cells defined by the matrix. The pressure sensorsmay be tactile pressure sensors that detect pressure applied by thepatient's tongue as the patient moves his or her tongue across thebottom surface of the bulb. The sensor may measure duration of pressure,direction of pressure, magnitude of pressure, or combinations thereof,at various cell locations.

Each pressure sensor may have its own signature signal. The signaturesignals are in electrical communication with a first interface. Thefirst interface accumulates pressure data from the various signaturesignals. This data is then used to create the pressure profile.

In this arrangement, the first interface sends the signature signal datavia a communications path. Preferably, the communications path is awireless communications path directed to a second interface. Thus, aspressure is sensed by a sensor (not shown) in the mouthpiece, the sensorsends a signal to the first interface, which is then communicated to thesecond interface.

Various types of sensors may be used. For example, a tactile pressuresensor may be used that relies upon resistive-based technology. In thisinstance the sensor acts as a variable resistor in an electricalcircuit. In this application, a small deflection of a matrix in themouthpiece causes implanted resistors to exhibit a change in ohmicvalue. The sensor converts this change into a voltage or otherelectrical signal that is interpreted as a continuous and linearpressure reading. When tactile pressure sensors are unloaded, theirresistance is very high. When force is applied, their resistancedecreases.

Additional sensing means may be incorporated into each cell in order tosense direction of pressure. In addition, a clock may be associated witheach signature signal to measure duration of a detected signal.

Other pressure-sensitive arrangements may be employed. In this respect,the embodiment is not limited by the type of sensor utilized within thecells. For example, a piezo-electric material may be used.

A processor (not shown) is communicably connected with the secondinterface, such as through a wireless communications system. Theprocessor processes the signature signals to translate location ofsensed pressure to a location of an object within a display. Theprocessor may also process the signature signals to translate magnitudeof sensed pressure, direction of sensed pressure relative to pressuresensed by at least one other sensor, and the duration of sensedpressure. The processor may manipulate an object within a display,relative to obstacles.

In practice, the patient applies selected pressure to the mouthpiece inorder to move an object across a display on a screen. The object ismanipulated around a track or over obstacles. The object is moved withinthe obstacle course in accordance with a pressure profile. The pressureprofile comprises at least one parameter defining an operating conditionof the mouthpiece. The at least one parameter is selected from the groupof parameters consisting of magnitude, direction, duration, andlocation. For example, the object could be a rabbit, the obstacle coursecould be a carrot field having fences or rows of vegetation, and therabbit could pursue carrots between the fences or rows of vegetationwhich serve as the obstacles.

While it will be apparent that the inventions herein described are wellcalculated to achieve the benefits and advantages set forth above, itwill be appreciated that the inventions are susceptible to modification,variation and change without departing from the spirit thereof.

1. An intra-oral system, comprising: an elastomeric mouthpiece comprising a bulb, the bulb having a plurality of air cells embedded therein configured to respond to pressure applied by the tongue of an individual; a plurality of air tubes, each air tube having a proximal end and a distal end, with the distal end of each of the air tubes being in substantially sealed fluid communication with a corresponding air cell; a plurality of transducers for converting changes in air pressure within the air cells to electrical signals, wherein each transducer is in substantially sealed fluid communication with the proximal end of a corresponding air tube; a processor for processing the electrical signals, wherein the electrical signals are modulated to generate a pressure profile from the air cells, the pressure profile representing a magnitude of pressure within air cells, a direction of pressure, a duration of pressure, or combinations thereof; and a display in operative electrical communication with the processor, the display having a visual output to move an object in accordance with the pressure profile.
 2. The intra-oral system of claim 1, wherein the mouthpiece is fabricated from polyisoprene rubber, silicon, chloroprene rubber, neoprene, styrene butadiene rubber, acrylonitrile butadiene rubber, ethylene propylene diene methylene, polyvinylchloride, polyethylene, polyurethane, urethane-coated nylon, ethyl vinyl acetate, and combinations thereof.
 3. The intra-oral system of claim 1, wherein the bulb comprises at least three outer air cells disposed radially around a centerpoint.
 4. The intra-oral system of claim 3, wherein the centerpoint defines a separate central air cell in fluid communication with one of the plurality of air tubes.
 5. The intra-oral therapeutic system of claim 1, wherein: each of the plurality of air tubes has an inner diameter of about 0.05 inches to 0.5 inches; and each of the plurality of air tubes resides substantially at ambient pressure.
 6. The intra-oral system of claim 1, wherein each of the plurality of air tubes is pre-loaded at a pressure of about 15 psi to 25 psi.
 7. The intra-oral system of claim 1, wherein: the intra-oral system further comprises a manifold; and each of the plurality of air tubes comprises more than one tubular body operatively connected to form a single, pneumatically sealed channel by connections to the manifold.
 8. The intra-oral system of claim 1, wherein each of the plurality of transducers is a pressure sensor having a diaphragm that is sensitive to changes in pressure within an air tube.
 9. The intra-oral system of claim 8, wherein the signal processor receives electrical signals from each of the plurality of transducers and processes those signals such that: each electrical signal represents an air pressure reading from a corresponding air cell; and electrical signals from one or more corresponding air cells are averaged over a specified period of time to produce the pressure profile, the pressure profile having a peak indicative of location at which air pressure is being generated within the one or more air cells during the specified period of time.
 10. The intra-oral system of claim 9, wherein: a magnitude of each electrical signal is recorded as part of the pressure profile over the specified period of time; and the object is caused to be moved on the display in the direction indicated by the pressure profile.
 11. The intra-oral system of claim 10, wherein: the object is further caused to be moved on the display at a velocity that corresponds to the magnitude of the electrical signals.
 12. The intra-oral system of claim 10, wherein the electrical signal is a voltage signal.
 13. The intra-oral system of claim 9, wherein the bulb comprises at least three outer air cells disposed radially around a centerpoint.
 14. The intra-oral system of claim 13, wherein an application of pressure by a patient on the centerpoint for a specified period of time and at a specified magnitude causes a location of the object to be reset to a beginning point on the display.
 15. The intra-oral system of claim 13, wherein an application of pressure by a patient on a designated outer air cell for a specified period of time and at a specified magnitude causes a location of the object to be moved to a corresponding location on the display.
 16. The intra-oral system of claim 13, wherein an application of pressure by a patient on the centerpoint for a specified period of time and at a specified magnitude causes the object to jump over an obstacle on the display.
 17. The intra-oral system of claim 13, wherein a double-clicking of application of pressure by a patient on the centerpoint for a specified period of time and at a specified magnitude: causes a location of the object to be reset to a beginning point on the display, causes the object to jump over an obstacle on the display, or causes an electrical apparatus to be activated.
 18. The intra-oral system of claim 13, wherein the centerpoint defines a separate air cell in fluid communication with one of the plurality of air tubes.
 19. A method for improving oral motor skills of a patient, comprising: providing an intra-oral therapeutic system, the intra-oral therapeutic system comprising: an elastomeric mouthpiece comprising a bulb, the bulb having a plurality of air cells embedded therein for receiving pressure applied by the tongue of a patient, a plurality of air tubes, each air tube having a proximal end and a distal end, with the distal end of each of the air tubes being in substantially sealed fluid communication with a corresponding air cell, a plurality of transducers for converting changes in air pressure within the air cells to electrical signals, each transducer being in sealed fluid communication with the proximal end of a corresponding air tube; and a processor for processing the electrical signals, wherein the electrical signals are modulated to generate a pressure profile from the air cells, the pressure profile representing a magnitude of pressure with the air cells, a direction of pressure, a duration of pressure, or combinations thereof; placing the plurality of air tubes in fluid communication with the corresponding plurality of transducers; placing the processor in operative electrical communication with a display, the display having a visual output; and by means of lingual manipulation, causing an object on the display to move in accordance with the pressure profile.
 20. The method of claim 19, wherein the mouthpiece is fabricated from polyisoprene rubber, silicon, chloroprene rubber, neoprene, styrene butadiene rubber, acrylonitrile butadiene rubber, ethylene propylene diene methylene, polyvinylchloride, polyethylene, polyurethane, urethane-coated nylon, ethyl vinyl acetate, and combinations thereof.
 21. The method of claim 19, wherein the bulb comprises at least three outer air cells disposed radially around a centerpoint.
 22. The method of claim 21, wherein the centerpoint defines a separate air cell in fluid communication with one of the plurality of air tubes.
 23. The method of claim 19, wherein: each of the plurality of air tubes resides substantially at ambient pressure; and each of the plurality of air tubes has an inner diameter of about 0.05 inches to 0.5 inches.
 24. The method of claim 19, wherein each of the plurality of air tubes is pre-loaded at a pressure of about 15 psi to 25 psi.
 25. The method of claim 19, wherein each of the plurality of transducers is a pressure sensor having a diaphragm that is sensitive to changes in pressure within an air tube.
 26. The method of claim 19, wherein the signal processor receives electrical signals from each of the plurality of transducers and processes those signals such that: each electrical signal represents an air pressure reading from a corresponding air cell; and electrical signals from one or more corresponding air cells are averaged over a specified period of time to produce the pressure profile, the pressure profile having a peak indicative of location at which air pressure is being generated within the one or more air cells during the specified period of time.
 27. The method of claim 26, wherein: p1 a magnitude of each electrical signal is recorded as part of the pressure profile over the specified period of time; and the object is caused to be moved on the display in the direction indicated by the pressure profile at a velocity that corresponds to the magnitude of the electrical signals.
 28. The method of claim 26, wherein the bulb comprises at least three outer air cells disposed radially around a centerpoint.
 29. The method of claim 28, wherein an application of pressure by a patient on the centerpoint for a specified period of time and at a specified magnitude causes a location of the object to be reset to a beginning point on the display.
 30. The method of claim 28, wherein an application of pressure by a patient on a designated outer air cell for a specified period of time and at a specified magnitude causes a location of the object to be moved to a corresponding location on the display.
 31. The method of claim 28, wherein an application of pressure by a patient on the centerpoint for a specified period of time and at a specified magnitude causes the object to jump over an obstacle on the display.
 32. The method of claim 28, wherein a double-clicking of application of pressure by a patient on a centerpoint for a specified period of time and at a specified magnitude: causes a location of the object to be reset to a beginning point on the display, causes the object to jump over an obstacle on the display, or causes an electrical apparatus to be activated.
 33. The method of claim 28, wherein the centerpoint defines a separate air cell in fluid communication with one of the plurality of air tubes.
 34. A method for manipulating an electrical apparatus using lingual musculature, comprising: providing an intra-oral system comprising: an elastomeric mouthpiece comprising a bulb, the bulb having a plurality of air cells embedded therein for receiving pressure applied by the tongue of a user, a plurality of air tubes, each air tube having a proximal end and a distal end, with the distal end of each of the air tubes being in substantially sealed fluid communication with a corresponding air cell, a plurality of transducers for converting changes in air pressure within the air cells to electrical signals, each transducer being in sealed fluid communication with the proximal end of a corresponding air tube; and a processor for processing the electrical signals, wherein the electrical signals are modulated to generate a pressure profile from the air cells, the pressure profile representing a magnitude of pressure within the air cells, a direction of pressure, a duration of pressure, or combinations thereof; placing the plurality of air tubes in fluid communication with the corresponding plurality of transducers; placing the processor in operative electrical communication with a display, the display having a visual output; causing an object on the display to move in accordance with the pressure profile; selecting a symbol on the display; and clicking on the symbol on the display.
 35. The method of claim 34, wherein the mouthpiece is fabricated from polyisoprene rubber, silicon, chloroprene rubber, neoprene, styrene butadiene rubber, acrylonitrile butadiene rubber, ethylene propylene diene methylene, polyvinylchloride, polyethylene, polyurethane, urethane-coated nylon, ethyl vinyl acetate, and combinations thereof.
 36. The method of claim 34, wherein the bulb comprises at least three outer air cells disposed radially around a centerpoint.
 37. The method of claim 36, wherein the centerpoint defines a separate air cell in fluid communication with one of the plurality of air tubes.
 38. The method of claim 36, wherein: each of the plurality of air tubes resides substantially at ambient pressure; and each of the plurality of air tubes has an inner diameter of about 0.05 inches to 0.5 inches.
 39. The method of claim 36, wherein the symbol on the display comprises a picture, one or more alphanumeric characters, an arrow, or a geometric figure.
 40. The method of claim 34, wherein each of the plurality of transducers is a pressure sensor having a diaphragm that is sensitive to changes in pressure within an air tube.
 41. The method of claim 34, wherein the signal processor receives voltage signals from each of the plurality of transducers and processes those signals such that: each voltage signal represents an air pressure reading from a corresponding air cell; and voltage signals from one or more corresponding air cells are averaged over a specified period of time to produce the pressure profile, the pressure profile having a peak indicative of location at which air pressure is being generated within the one or more air cells during the specified period of time.
 42. The method of claim 34, wherein the electrical apparatus is a wheelchair, a light fixture, a television, or an electro-mechanically operated door.
 43. The method of claim 34, wherein the bulb comprises at least three outer air cells disposed radially around a centerpoint.
 44. The method of claim 43, wherein an application of pressure by a patient on the centerpoint for a specified period of time and at a specified magnitude causes a location of the object to be reset to a beginning point on the display.
 45. The method of claim 43, wherein an application of pressure by a patient on a designated outer air cell for a specified period of time and at a specified magnitude causes a location of the object to be moved to a corresponding location on the display.
 46. The method of claim 43, wherein clicking on a symbol on the display constitutes a double-clicking of application of pressure by a patient on a centerpoint for a specified period of time and at a specified magnitude.
 47. The method of claim 43, wherein the centerpoint defines a separate air cell in fluid communication with one of the plurality of air tubes.
 48. The method of claim 43, wherein: the display further comprises a keyboard; selecting a symbol on the display comprises selecting a series of characters on the keyboard; and clicking on the symbol on the display comprises composing a textual message.
 49. The method of claim 48, further comprising: sending the textual message through a wireless communications system.
 50. The method of claim 43, wherein: selecting a symbol on the display comprises selecting a directional key; and clicking on the symbol on the display causes a wheelchair or a bed to move.
 51. The method of claim 43, wherein: selecting a symbol on the display comprises selecting an icon representing an electrical apparatus; and clicking on the symbol on the display causes the apparatus to be turned on or turned off.
 52. The method of claim 51, further comprising: selecting a symbol on the display further comprises selecting a directional key; and clicking on the symbol on the display causes a condition of the apparatus to be changed.
 53. The method of claim 52, wherein the electrical apparatus is a light fixture, a television, a radio, or a mechanically operated door. 